Effect of Rosuvastatin in Abdominal Sepsis

Official Title: “Use of Rosuvastatin in Integral Management of Abdominal Sepsis”

The purpose of this study is to determine whether rosuvastatin is effective as a coadjuvant drug in the integral management of abdominal sepsis acknowledged by surgery.

The sepsis is often lethal, the mortality's ranks are identified among 25 to 70%, this depends on definition, severity and co-morbidities. The number of deaths by sepsis could be similar to myocardial infarct. Patients who get shock have 26-fold risk of death.

In preliminary studies have been observed, that patients with treatment with statin have minor incidence of severe sepsis. A retrospective study suggests the association between using statins and reduction of bacteriemia by Gram negatives and S. aureus.

There are many experimental studies which demonstrate the possible profit in sepsis. However there are no clinical prospective studies for determinate if statins are effective in management of sepsis. The investigators designed this study to demonstrate the utility of rosuvastatin in one kind of sepsis, abdominal sepsis.

Intervention(s) in this Clinical Trial

• Drug: Rosuvastatin
  • 20 mg 10 days daily since abdominal sepsis diagnosis

Primary Measures

• Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL)
  • Time Frame: day 3
    Safety Issue?: No

Secondary Measures

• Number of survivors
  • Time Frame: 1 week after randomization
    Safety Issue?: No
• Plasmatic levels of Reactive C Protein (mg/dL)
  • Time Frame: day 3
    Safety Issue?: No
• Classification of severity by APACHE II scale
  • Time Frame: day 3
    Safety Issue?: No
• Incidence of complications or secondary effects
  • Time Frame: day 1, 3, 7, 14 after randomization
    Safety Issue?: Yes

Inclusion Criteria:

• 1. Man or women > 18 and < 80 years old with abdominal sepsis, confirmed diagnosis by surgery of broad peritonitis before 48 hours in progression
• 2. Injury by steel or firearm with contaminated abdominal cavity
• 3. APACHE II major or equal than 8
• 4. Acceptance to be included

Exclusion Criteria:

• 1. Ingestion of: fibrates, niacin, cyclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem, amiodarone
• 2. Hypovolemic shock III and IV after get surgery
• 3. Cardio-respiratory failure pre or trans surgery
• 4. Allergy to used drug
• 5. Use previous of statin
• 6. Hepatopathy or myopathy and(or) history, hepatic failure (Child B y C)
• 7. Management in other Hospital
• 8. Pregnancy
• 9. Thoracic injury, head injury (moderate and severe), multiple fractures or with bone exposition, rectal injury

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Universidad Autonoma de San Luis Potosí Other

Overall Clinical Trial Officials and Contacts

Martin Sanchez-Aguilar, MSc Principal Investigator Experimental Surgery , Universidad Autonoma de San Luis Potosi  

Overall Contact: Martin Sanchez-Aguilar, MSc 524448262345 jemarsan7@hotmail.com

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00357123

Study ID Number: 28-08 ROAS

ClinicalTrials.gov Identifier: NCT00357123

Health Authority: Mexico: National Institute of Public Health, Health Secretariat